Dextroamphetamine 2.5mg Tablets

Manufacturer WINDER LABORATORIES Active Ingredient Dextroamphetamine Tablets(deks troe am FET a meen) Pronunciation deks troe am FET a meen
WARNING: This drug has a high risk of misuse. This can lead to alcohol or drug use disorder. Misuse or abuse of this drug can lead to overdose or death. The risk is higher with higher doses or when used in ways that are not approved like snorting or injecting it. Do not give this drug to anyone else. This drug may also be habit-forming if taken for a long time. Do not take for longer than you have been told by your doctor. Use only as you were told. Tell your doctor if you have ever had alcohol or drug use disorder. You will be watched closely while taking this drug. Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. Throw away unused or expired drugs as you have been told. @ COMMON USES: It is used to treat attention deficit problems with hyperactivity.It is used to treat narcolepsy.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Central Nervous System (CNS) Stimulant
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Pharmacologic Class
Sympathomimetic amine; norepinephrine-dopamine reuptake inhibitor and releaser
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Pregnancy Category
Category C
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FDA Approved
Feb 1952
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DEA Schedule
Schedule II

Overview

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What is this medicine?

Dextroamphetamine is a stimulant medication used to help people with Attention-Deficit/Hyperactivity Disorder (ADHD) improve focus, attention, and control impulsive behaviors. It is also used to treat narcolepsy, a condition that causes extreme daytime sleepiness.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food. To minimize the risk of sleep disturbances, avoid taking it late in the day. Additionally, do not take this medication with fruit juice. Establish a routine by taking your medication at the same time every day.

Storing and Disposing of Your Medication

Keep your medication at room temperature, away from direct light and moisture. Avoid storing it in a bathroom. To prevent accidental ingestion, store your medication in a secure location where children and pets cannot access it. Consider using a locked box or designated area to keep your medication safe from others. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on proper disposal methods, which may include participating in a local drug take-back program.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Take exactly as prescribed by your doctor. Do not take more or less than directed, or more often than prescribed.
  • Avoid taking doses late in the day to prevent sleep problems.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Do not stop taking this medication suddenly, especially after prolonged use, without consulting your doctor, as withdrawal symptoms may occur.
  • Maintain a healthy diet and monitor your weight, especially for children, as appetite suppression can occur.
  • Avoid alcohol consumption while taking this medication.
  • Store in a safe place to prevent misuse or diversion.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by indication and patient response
Dose Range: 2.5 - 60 mg

Condition-Specific Dosing:

ADHD: Initial 5 mg once or twice daily; titrate by 5 mg weekly to a maximum of 40 mg/day (divided doses).
Narcolepsy: Initial 10 mg daily; titrate by 10 mg weekly to a maximum of 60 mg/day (divided doses).
Obesity (historical use): 5-10 mg 30-60 minutes before meals, 1-3 times daily; maximum 30 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: ADHD (6-12 years): Initial 2.5-5 mg once or twice daily; titrate by 2.5-5 mg weekly to a maximum of 40 mg/day (divided doses). Narcolepsy (6-12 years): Initial 5 mg daily; titrate by 5 mg weekly to a maximum of 60 mg/day (divided doses).
Adolescent: ADHD (13-17 years): Initial 5 mg once or twice daily; titrate by 5 mg weekly to a maximum of 40 mg/day (divided doses). Narcolepsy (13-17 years): Initial 10 mg daily; titrate by 10 mg weekly to a maximum of 60 mg/day (divided doses).
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended
Moderate: No specific adjustment recommended
Severe: Dose reduction may be necessary (e.g., CrCl < 30 mL/min); monitor for adverse effects.
Dialysis: Considerations: Dextroamphetamine is not significantly dialyzable. Use with caution and monitor.

Hepatic Impairment:

Mild: No specific adjustment recommended
Moderate: No specific adjustment recommended
Severe: Use with caution; consider lower starting doses and slower titration due to hepatic metabolism (CYP2D6).

Pharmacology

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Mechanism of Action

Dextroamphetamine is a sympathomimetic amine that acts as a central nervous system (CNS) stimulant. It is believed to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. The therapeutic effects in ADHD and narcolepsy are thought to be mediated through the modulation of these neurotransmitter systems in the brain.
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Pharmacokinetics

Absorption:

Bioavailability: 75-100%
Tmax: 2-4 hours (immediate release)
FoodEffect: Food can delay absorption but does not significantly affect the extent of absorption.

Distribution:

Vd: 3-5 L/kg
ProteinBinding: Approximately 15-20%
CnssPenetration: Yes

Elimination:

HalfLife: 10-12 hours (adults); 6-8 hours (children)
Clearance: Not readily available (highly variable due to pH-dependent excretion)
ExcretionRoute: Renal (urine)
Unchanged: 30-40% (highly dependent on urinary pH; increased in acidic urine, decreased in alkaline urine)
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Pharmacodynamics

OnsetOfAction: 30-60 minutes (immediate release)
PeakEffect: 2-4 hours
DurationOfAction: 4-6 hours (immediate release)

Safety & Warnings

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BLACK BOX WARNING

AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE AND MUST BE AVOIDED. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF PATIENTS OBTAINING AMPHETAMINES FOR NONTHERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE USUAL PRECAUTIONS OF THE CONTROLLED SUBSTANCE ACT SHOULD BE OBSERVED. MISUSE OF AMPHETAMINES MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Restlessness
Shakiness
Trouble controlling body movements
Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Changes in eyesight or eye pain, swelling, or redness
Erectile dysfunction
Decreased sex interest
Seizures
Stomach pain
Muscle pain or weakness, dark urine, or trouble passing urine
Frequent or prolonged erections
Changes in skin color, such as pale, blue, gray, purple, or red discoloration of hands, feet, or other areas
Numbness, pain, tingling, or cold sensation in hands or feet
Sores or wounds on fingers or toes

Important Heart-Related Warnings

If you have a pre-existing heart condition or heart defect, inform your doctor. Additionally, if a family member has a history of abnormal heartbeat or sudden death, notify your doctor. Seek immediate medical attention if you experience any signs of heart problems, such as:

Chest pain
Abnormal heartbeat
Shortness of breath
Severe dizziness or fainting

Serotonin Syndrome: A Potentially Life-Threatening Condition

Taking this medication with certain other drugs can increase the risk of serotonin syndrome, a severe and potentially deadly condition. If you experience any of the following symptoms, contact your doctor right away:

Agitation
Changes in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, nausea, or vomiting
Severe headache

Other Possible Side Effects

While many people may not experience any side effects or only minor ones, it's essential to be aware of the following potential side effects:

Dizziness or headache
Dry mouth
Trouble sleeping
Constipation, diarrhea, upset stomach, or decreased appetite
Weight loss
Bad taste in mouth
Feeling nervous and excitable
Hair loss

If you experience any of these side effects or any other symptoms that concern you, contact your doctor for guidance. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Chest pain, shortness of breath, or fainting (syncope)
  • Fast or pounding heartbeat
  • New or worsening mental problems (e.g., hallucinations, paranoia, aggression, mania)
  • New tics or worsening of existing tics
  • Unexplained fever, muscle stiffness, or severe headache (signs of serotonin syndrome)
  • Numbness, pain, or discoloration in fingers or toes
  • Blurred vision or other vision changes
  • Seizures
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
A history of certain health conditions, including:
+ Blood vessel disease
+ High blood pressure
+ Heart structure problems or other heart-related issues
+ Tourette's syndrome or tics (you or a family member)
Existing health problems, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid
Past health issues, including:
+ Drug abuse
+ Stroke
Current medications, particularly:
+ Acetazolamide
+ Sodium bicarbonate
+ Certain antidepressants or Parkinson's disease medications taken in the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline (as they may cause very high blood pressure)
+ Linezolid or methylene blue
If you are breastfeeding, as you should not breastfeed while taking this medication.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine the safety of taking this medication with your other drugs and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor.
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Precautions & Cautions

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

When starting this medication, avoid driving and other activities that require alertness and clear vision until you understand how it affects you.

Long-term or high-dose use of this medication can lead to tolerance, where the medication may not work as well, and higher doses may be needed to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not exceed the prescribed dose.

Prolonged or regular use of this medication may cause dependence. Stopping the medication abruptly can lead to withdrawal symptoms. Consult your doctor before reducing the dose or discontinuing the medication, and follow their instructions. Report any adverse effects to your doctor.

Before initiating treatment, you may need to undergo heart tests. If you have questions or concerns, discuss them with your doctor.

This medication may cause high blood pressure. Monitor your blood pressure and heart rate as directed by your doctor. Be aware of signs of high blood pressure, such as severe headaches, dizziness, fainting, or changes in vision, and contact your doctor immediately if you experience any of these symptoms.

When using over-the-counter (OTC) products, consult your doctor before taking medications that may increase blood pressure, including cough and cold remedies, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.

This medication may affect the results of certain laboratory tests. Inform all your healthcare providers and laboratory personnel that you are taking this medication.

There is a potential increased risk of seizures associated with this medication, particularly in individuals with a history of seizures. Discuss your risk with your doctor.

This medication may cause changes in behavior and mood, including altered thinking, anger, and hallucinations. If you or a family member have a history of mental or mood disorders, such as depression or bipolar illness, or if a family member has committed suicide, inform your doctor. Contact your doctor immediately if you experience hallucinations, changes in behavior, or signs of mood changes, such as depression, suicidal thoughts, nervousness, emotional instability, abnormal thinking, anxiety, or loss of interest in life.

In children and adolescents, this medication may affect growth in some cases. Regular growth checks may be necessary. Discuss this with your doctor.

If you are pregnant or plan to become pregnant, consult your doctor to weigh the benefits and risks of using this medication during pregnancy.
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Overdose Information

Overdose Symptoms:

  • Restlessness
  • Tremor
  • Hyperreflexia (overactive reflexes)
  • Rapid breathing
  • Confusion
  • Hallucinations
  • Panic states
  • High fever (hyperpyrexia)
  • Rhabdomyolysis (muscle breakdown)
  • Convulsions
  • Coma
  • Cardiac arrhythmias
  • Hypertension or hypotension
  • Circulatory collapse

What to Do:

Call 911 or your local emergency number immediately. For poison control, call 1-800-222-1222.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of MAOI discontinuation (risk of hypertensive crisis)
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Major Interactions

  • Other sympathomimetic agents (e.g., decongestants, other stimulants) - additive cardiovascular effects
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans) - increased risk of serotonin syndrome
  • Antihypertensive agents - may decrease the hypotensive effect of these drugs
  • Tricyclic antidepressants (TCAs) - may potentiate the effects of dextroamphetamine
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Moderate Interactions

  • Urinary acidifiers (e.g., ammonium chloride, ascorbic acid) - decrease dextroamphetamine absorption and increase excretion, reducing efficacy
  • Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide) - increase dextroamphetamine absorption and decrease excretion, increasing toxicity risk
  • CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine) - may increase dextroamphetamine plasma concentrations
  • Antipsychotics - may antagonize the stimulant effects of dextroamphetamine
  • Antihistamines - may potentiate CNS effects
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: Risk of cardiovascular adverse events (hypertension, tachycardia)

Timing: Prior to initiation

Weight and Height (Pediatric)

Rationale: Risk of growth suppression

Timing: Prior to initiation

Psychiatric History (e.g., psychosis, bipolar disorder, tics)

Rationale: Risk of exacerbation of pre-existing psychiatric conditions or new-onset symptoms

Timing: Prior to initiation

Family History of Sudden Cardiac Death or Arrhythmias

Rationale: To assess underlying cardiac risk

Timing: Prior to initiation

Electrocardiogram (ECG)

Rationale: Consider if patient has pre-existing cardiac conditions or concerning family history

Timing: Prior to initiation (if indicated)

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: At each visit (e.g., every 3-6 months)

Target: Within normal limits for age

Action Threshold: Persistent elevation above normal range; consider dose reduction or discontinuation

Weight and Height (Pediatric)

Frequency: Every 3-6 months

Target: Consistent growth trajectory

Action Threshold: Significant growth deceleration or weight loss; consider drug holiday or alternative treatment

Psychiatric Status (e.g., agitation, anxiety, psychosis, mania, tics)

Frequency: At each visit

Target: Stable or improved

Action Threshold: New-onset or worsening psychiatric symptoms; consider dose adjustment or discontinuation

Abuse/Diversion Potential

Frequency: At each visit

Target: No signs of misuse

Action Threshold: Signs of abuse or diversion; implement appropriate management strategies

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Symptom Monitoring

  • Chest pain
  • Shortness of breath
  • Syncope (fainting)
  • New-onset or worsening psychosis (hallucinations, delusions)
  • Mania or hypomania
  • Aggression or hostility
  • New-onset or worsening tics
  • Severe headache
  • Unexplained fever
  • Muscle stiffness or rigidity
  • Changes in vision

Special Patient Groups

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Pregnancy

Dextroamphetamine is classified as Pregnancy Category C. Studies in animals have shown adverse effects on the fetus, and there are no adequate and well-controlled studies in pregnant women. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of congenital malformations (e.g., cardiac defects, oral clefts) based on some studies, though data are conflicting.
Second Trimester: Potential for fetal growth restriction and premature birth.
Third Trimester: Risk of neonatal withdrawal symptoms (e.g., agitation, tremor, feeding difficulties) if used close to delivery.
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Lactation

Dextroamphetamine is excreted into breast milk. The American Academy of Pediatrics considers amphetamines to be a drug for which the effect on the nursing infant is unknown but may be of concern. LactMed rates it as L3 (Moderately Safe).

Infant Risk: Monitor breastfed infants for signs of irritability, poor feeding, poor weight gain, and sleep disturbances. The long-term effects on neurodevelopment are unknown. Consider alternative treatments or discontinuing breastfeeding, especially with higher doses.
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Pediatric Use

Monitor growth (height and weight) carefully, as growth suppression can occur. Monitor for emergence or exacerbation of psychiatric symptoms (e.g., psychosis, mania, tics). Long-term safety and efficacy in children under 6 years of age have not been established.

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Geriatric Use

Use with caution in elderly patients. Start with lower doses and titrate slowly due to increased sensitivity to adverse effects, particularly cardiovascular and psychiatric effects. Monitor cardiovascular status closely.

Clinical Information

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Clinical Pearls

  • Dextroamphetamine has a high potential for abuse and dependence; careful prescribing and monitoring are essential.
  • Monitor cardiovascular vital signs (BP, HR) regularly due to risk of hypertension and tachycardia.
  • Growth suppression can occur in children; monitor height and weight and consider drug holidays if growth is significantly affected.
  • Psychiatric adverse events, including new-onset psychosis or mania, can occur; screen for personal or family history of psychiatric disorders.
  • Avoid abrupt discontinuation after prolonged high-dose use to prevent withdrawal symptoms (e.g., severe fatigue, depression).
  • Urinary pH can significantly affect dextroamphetamine excretion; acidic urine increases excretion, while alkaline urine decreases it.
  • Inform patients about potential for sleep disturbances and advise against late-day dosing.
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Alternative Therapies

  • Methylphenidate (Ritalin, Concerta, Focalin)
  • Atomoxetine (Strattera)
  • Guanfacine extended-release (Intuniv)
  • Clonidine extended-release (Kapvay)
  • Bupropion (Wellbutrin) - off-label for ADHD
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Cost & Coverage

Average Cost: Varies widely per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic); Tier 3 or higher (brand)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.